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Revisiting the ROSE Trial - Why Did Participants with ARDS Identified as Hispanic/Latino Have Lower Mortality When Randomized to Receive Early Neuromuscular Blockade?
American Journal of Respiratory and Critical Care Medicine ; 205(1), 2022.
Article in English | EMBASE | ID: covidwho-1927743
ABSTRACT
Rationale The ROSE trial was a multicenter unblinded randomized clinical trial comparing early neuromuscular blockade (NMB) to usual care in patients with moderate to severe ARDS (NEJM 2019). This trial (n=1006) was stopped early for futility yet a subgroup analysis found that among Hispanic/Latino participants the NMB intervention group had a significantly lower mortality (32%) compared to those in the control group (53.7% p=0.02 for interaction). To evaluate potential contributors to these differences we compared baseline clinical and biological characteristics among Hispanic/Latino participants in the intervention vs control group.

Methods:

We compared demographics primary ARDS risk factor illness severity ventilatory parameters comorbidities and plasma biomarkers at baseline between the NMB intervention and control group for all 118 Hispanic/Latino patients recruited to the ROSE trial (11.6% of the trial population). We used multiple logistic regression to examine whether the mortality difference by treatment group would persist after controlling for the factors that differed significantly between groups.

Results:

At baseline Hispanic/Latino participants randomized to the control group had greater disease severity scores (APACHE III SOFA;p<0.05 for both) and a higher prevalence of shock (p=0.01) compared to those randomized to the intervention. There were no significant differences between groups in causes of lung injury or baseline ventilatory parameters. In an unadjusted logistic regression model the NMB intervention was significantly associated with mortality (OR 0.42;95%CI 0.20-0.89 p=0.02). The NMB intervention was no longer significantly associated with mortality when adjusting for severity of by illness by either SOFA score (OR 0.53;95%CI 0.24-1.20 p=0.13), APACHE III (OR 0.51, 95%CI 0.20- 1.30 p=0.16) or shock as defined by the need for vasopressors (OR 0.48, 95%CI 0.22-1.03, p=0.06). Hispanic/Latino participants in the control group had significantly higher interleukin-8 (p=0.02) and lower bicarbonate (p=0.045) than those in the intervention group.

Conclusion:

Together these clinical and biomarker data support the conclusion that the lower mortality associated with NMB in the Hispanic/Latino subgroup may have been partially due to baseline imbalances in systemic severity of illness. This finding underscores the need to cautiously interpret apparent treatment benefits within small subgroups. The COVID-19 pandemic has highlighted ethnic and racial disparities in ARDS. Future trials will benefit from increased representation of populations that are disproportionately affected to minimize the impact of spurious findings related to small sample sizes while creating more statistical power to prospectively address disparities.
Keywords

Full text: Available Collection: Databases of international organizations Database: EMBASE Type of study: Experimental Studies / Randomized controlled trials Language: English Journal: American Journal of Respiratory and Critical Care Medicine Year: 2022 Document Type: Article

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Full text: Available Collection: Databases of international organizations Database: EMBASE Type of study: Experimental Studies / Randomized controlled trials Language: English Journal: American Journal of Respiratory and Critical Care Medicine Year: 2022 Document Type: Article